New Jersey based Orphan and Ikaria, have announced that the FDA has accepted the final section of the New Drug Application (NDA) filing seeking marketing approval for Lucassin (terlipressin for injection) for the treatment of hepatorenal syndrome (HRS) Type 1.
In September 2008, Ikaria acquired the North American rights to Lucassin, including responsibility for manufacturing, distribution, marketing, sales, customer service and post-market development. Those rights will be transferred to Ikaria following marketing approval.
Lucassin is a synthetic vasopressin analogue that acts via the vasopressin V1 receptor as a systemic vasoconstrictor, mainly in the splanchnic (abdominal) circulation, which appears to increase effective arterial volume and improves renal blood flow, thereby improving renal function in patients with HRS.